The LATCHING Pilot Project

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Other: Usual prenatal care; Behavioral: Behavior Lifestyle Intervention

• Registration Number: NCT03442517
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to learn if group-based phone counseling is effective for increasing breastfeeding rates, reducing the early introduction of solids and increasing maternal weight loss after pregnancy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-29
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-22
• Status Verified: 2019-05
• Primary Completion: 2019-05-05
• Study Completion: 2019-05-05
• Last Update Submitted: 2019-05-29
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Women who are 9-30 weeks in gestation that have not previously met breastfeeding recommendations
• Speak and understand English

Exclusion Criteria

• Women with pregnancies conceived using fertility treatments, those at high risk for pre-term delivery, those with multiple gestation (ie. twins, triplets, etc), or pregnancies complicated by morbid obesity (BMI>40), diabetes (pre-gestational or gestational), hypertension, metabolic dysfunction, etc.
• Women who have previously exclusively breastfed an infant for three or more months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual prenatal care	Usual prenatal care	Participants will continue their usual prenatal care.
Group-based phone counseling (GBPC)	Behavior Lifestyle Intervention	Participants will take part in weekly group-based phone counseling sessions for 6 weeks starting between 16-30 weeks of pregnancy.

Primary Outcome Measures

Name	Time	Method
Proportion of women exclusively breastfeeding	Month 6
Differences in infant feeding progression	Month 6
Proportion of women who introduce solids	Month 4

Secondary Outcome Measures

Name	Time	Method
Study Retention	Month 6	Retention rates will be calculated from participants who complete feeding questionnaire data at 6 months.
Subject satisfaction and acceptability of intervention	Week 24	Structured interviews will be used to determine subject satisfaction. Structured interviews will obtain descriptive data regarding problems encountered by participants during the intervention, areas of intervention strength and weakness, information participants found helpful and information participants wish they had been given during the intervention, and ways the overall intervention could be improved.
Intervention compliance	Week 24	Compliance rates will be calculated from participants that attend at least 66.6% (at least 4 sessions) of GBPC sessions.

Trial Locations

Locations (3)

Priority Care Pediatrics, LLC; 🇺🇸 Kansas City, Missouri, United States

Northland Obstetrics & Gynecology, Inc.; 🇺🇸 Liberty, Missouri, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States